At Flowonix, our patient centric approach drives the design, development, and deployment of targeted drug delivery platforms whose sole purpose is to provide physicians an optimal solution for the treatment of their patients' numerous neurological disorders.
- Character – The common thread of our culture. One is never wrong doing what is right.
- Integrity – Saying exactly what we mean and doing what we say.
- Relentless – While never at the expense of progress, we push for perfection.
- Purpose – Optimizing patient outcomes is our greater cause.
It's the desire to help people with life-changing technology that drives every member of the Flowonix team. At Flowonix we believe our employees are an essential component to our long-term success, and it is this mindset that drives our commitment to offer unique career opportunities.
We are passionate about having a diverse and talented workforce to solve the big problems we are seeking to tackle. We offer a competitive health and benefits package.
Browse our current job openings below. If you do not see any current openings but are interested in joining our team, please feel free to send an email to firstname.lastname@example.org
Position Title: Director, Product Surveillance
Reports to: Senior Vice President, Clinical, Quality & Regulatory Affairs
The Director, Product Surveillance will provide strategic and tactical direction regarding post-market product surveillance.
Post-market product surveillance includes reactive surveillance generated from products used in the field (complaints), as well as proactive surveillance generated from information in the scientific literature and information obtained from manufacturing and quality system activities, including CAPA and risk management activities.
- The Director role provides strategic leadership and supervision of the Product Surveillance team in the execution of timely, high quality and consistent product complaints management, including appropriate identification and response to risks, adverse event reporting decisions, and collection and documentation of complaints. The scope of responsibility includes leadership for directing all Post Market Surveillance activities.
- Supervise, monitor, and engage Product Surveillance staff, while also managing the organizational structure and staffing for the Product Surveillance Team to ensure the management of product complaints is executed according to regulatory requirements and customer expectations.
- Harmonize the complaint handling process, ensure regulatory compliance, and drive continuous improvement within the product surveillance teams
- Establish and maintain strong relationships to enforce customer feedback investigations and to ensure that adequate corrective actions are being implemented in a timely manner, acting appropriately when things need to be escalated for senior management involvement.
- Lead interactions with other functions as required with respect to customer feedback investigation, assessing appropriateness of investigations and corrective actions.
- Lead the monitoring of the customer feedback and safety profile of products, including signal detection, and management of signal evaluation activities and documentation
- Use risk management skills to analyze adverse event information and determine if further adverse health outcome details are required for reportability decision-making, and determine if events are reportable to regulators.
- Manage the preparation of aggregate customer feedback reports, and consequent review of Risk Management Plans, relevant sections of regulatory documents and health authority responses
- Provide scientific input into evaluation of customer feedback
- Provide scientific input into safety documents and relevant sections of regulatory documents such as safety analyses, expert statements, submission dossiers, health authority responses, clinical study reports and protocols.
- Oversee development of safety data reviews for Clinical Evaluation Reports, Annual Reports and Health Hazard Assessments
Qualifications, Skills and Experience Required
- Bachelor’s Degree in an Engineering, Science or related discipline
- Clinically oriented degree preferred: PharmD., Ph.D., Nurse Practitioner, RN, PA, or M.D.
- Minimum of ten (10) years of experience with Post-Market Surveillance /Customer Complaints concepts, principles and systems
- Minimum of five (5) years of experience in the medical device industry, preferably with PMA devices
- Knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO13485.
- Working knowledge of product risk management for both pre-market development activities and post-market safety surveillance activities
- Demonstrated ability to organize, prioritize and manage safety compliance deliverables with a focus on patient safety and regulatory compliance.
- Previous experience in scientific/medical writing is desired
- Ability to read and analyze scientific and medical literature
- Experience building, growing and developing a post market surveillance team
- Ability to lead and manage at all levels of the organization.
- Strong analytical skills and attention to detail
- Strong project management and strategic planning skills
- Excellent interpersonal and communication skills, including proven verbal, written, and presentation skills
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Position Title: Technical Solutions Engineer
Reports to: Director, Field Support
Department: Customer Care
Location: Mt. Olive, NJ
Responsible for documenting and resolving technical issues received from customers and field representatives as well as coordinating and supporting multiple cross-functional in-house teams including sales education and training.
- Address questions from customers and patients about Flowonix products.
- Develop a strong working relationship with all members of the field engineering and Sales force.
- Ensure that technical service issues are well documented and resolved in a timely manner.
- Interface with complaint coordinator to ensure complaints are properly documented.
- Share clinical/technical experiences with other personnel in order to improve understanding of product behavior, improve product performance and product acceptance by customers.
- Coordinate and support in-house educational activities as requested by members of the team.
- Participate in weeknight and weekend on-call support rotation.
Decision Making Authority:
- Document and resolve all technical issues. Identify training needs and support materials in cooperation with other team members.
- Knowledge/Educational Requirements:
- Bachelor'r or graduate degree in engineering
- 3-4 years of experience implanting and following similiar medical devices
- Strong working knowledge of how the devices work, from an engineering perspective
- Excellent working knowledge of industry best practices for best-in-class customer service in a technical support environment
- Skills and Abilities:
- Highly flexible - able to adapt to changing business needs
- Solutions oriented - self-driven and analytical to provide potential solutions as new problems arise
- "Builder" mentality - individual who takes ownershp and desires to continue to improve processes and workflows
- Well rounded engineer who can understand both technical details and big picture scenarios, then communicate with multiple types of colleagues
- Ability to communicate with others, including verbal, written, and electronic communication
- Ability to quickly analyze and resolve clinical/technical issues
- Ability to work effectively under pressure in a fast-paced, time sensitive environment with shifting priorities and multiple deadlines
- Strong interpersonal, communication and analytical skills
- Physical Demands/Work Environment:
- Office-based responsibilities with occasional travel as necessary to support education activities
- Ability to maintain on-call servicing
Direct Reports - None
Indirect Reports - None
Internal Contacts - All personnel associated with field-based activities, R&D personnel, Regulatory Affairs and specialists.
External Contacts - Site personnel including; physicians, research coordinators, and oter support staff. Patients calling with questions about Flowonix Medical products.
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